On 29 September 2025, Gedeon Richter and Hikma Pharmaceuticals announced they have secured FDA approval for Enoby™ (RGP-14-P) and Xtrenbo™ (RGP-14-P) (denosumab-qbde), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.
Hikma and Richter entered into a licence and commercialisation agreement for RGB-14 in December 2021. Under the terms of the agreement, Richter is responsible for the development and manufacture of RGB-14, and Hikma is responsible for FDA registration and has exclusive rights to commercialise it in the US.
Richter/Hikma’s denosumab biosimilars are the seventh pair to be approved in the US, following Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched) and Biocon’s Bosaya™ and Aukelso™ (approved September 2025, not yet launched).
On 25 June 2025, Amgen filed BPCIA litigation in the US District Court for the District of New Jersey against Hikma and Richter, asserting infringement of 32 patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products. The litigation followed the FDA’s acceptance in December 2024 of Richter/Hikma’s BLA for RGB-14-P and RGB-14-X. Although Amgen has settled five of its denosumab BPCIA proceedings against other biosimilar manufacturers, the Richter/Hikma proceedings currently remain pending.